Documentation & COAs

Lot-specific Certificates of Analysis from two independent laboratories, available to review before you order. Here is what is on them and how to read one.

  • FDA-Registered Facility
  • cGTP-Compliant (21 CFR Part 1271)
  • Dual-Lab COA Verified
  • NTA-Verified
  • USA Manufactured
Apply for wholesale accessRequest documentation

How to read a COA

Six things to check on any Certificate of Analysis, from any supplier.

  1. Lot numberIt should match the lot printed on your vial. A COA without a lot number, or covering many lots, is not lot-specific.
  2. Testing laboratoryThe lab that ran the tests should be named. With dual-lab verification you receive two reports from two labs.
  3. MethodEach result should cite how it was measured, for example USP <71> for sterility or NTA for particle counts.
  4. SpecificationThe acceptance limit the lot had to meet. A result without a specification cannot pass or fail.
  5. ResultThe measured value for this lot, not a typical or historical value.
  6. Release and sign-offA release decision with a reviewer signature and date.

The certificate above is an illustrative layout with placeholder values, not Stem Nova lot data.

Two reports, one lot

Dual-lab verification means two separate test reports from two different facilities. It is not a field on the COA itself.

Manufacturing lab report

  • In-process quality control during production
  • Sterility and endotoxin on each lot
  • Mycoplasma screening
  • Release testing before distribution

Independent lab report

  • Third-party confirmation of the manufacturer's results
  • Separate sterility and endotoxin verification
  • Viral panel confirmation for hUCT-MSC lots
  • Additional NTA characterization for exosome lots
You receive bothCompare them side by side and keep both in your compliance files.

What is on each COA

Testing matched to each product category.

Field Exosome products hUCT-MSC
Sterility (21 CFR 610.12 / USP <71>) Yes Yes
Endotoxin Yes Yes
Mycoplasma (PCR) Yes Yes
NTA particle count & size, final product Yes —
Cell count — Yes
Post-thaw viability — Yes
Identity markers (flow cytometry, ISCT) — Yes
Viral panel — Yes
Donor eligibility & tissue source records Yes Yes

Passage number and population doublings are not standard COA fields. Ask any supplier how expansion history is tracked; see Population Doublings & Passages.

NTA on the final product

Exosome particle counts are measured on the finished, shipped product, not on a pre-processing sample.

Illustrative nanoparticle tracking analysis report.
Illustrative NTA report layout. Example values only; not Stem Nova lot data.
  • Measured by NanoSight NTA on every exosome lot.
  • Shows particle concentration and size distribution.
  • Verified by the independent lab, separate from manufacturing.
  • Labeled count = concentration × fill volume.
How to read an NTA report →

Questions to ask any supplier

Use these with us or anyone else.

  1. Is every COA lot-specific?

    Does the certificate match the lot number you received, or cover many lots?

  2. Who ran the tests?

    Which laboratories tested the lot, and was any result verified by a separate facility?

  3. Was NTA run on the shipped product?

    Or on a pre-processing sample that may not reflect what is in the vial?

  4. Which tests are lot-level?

    Which results come from testing this lot, and which come from donor screening?

  5. What viral panel is included?

    How many markers, and is testing done on the lot or only on the donor?

  6. What viability is documented after thaw?

    For cell products, what post-thaw viability is on the COA, and who measured it?

  7. Liquid or lyophilized?

    Preservation format changes storage, handling and reconstitution requirements.

  8. Is sterility tested per 21 CFR 610.12?

    And on each individual lot rather than representative samples?

How to request documentation

Available before and after you order.

  1. Ask

    Contact your account representative or use our contact page.

  2. Identify the lot

    We locate the documentation for your order or the product you are evaluating.

  3. Receive both reports

    Dual-lab COAs plus all applicable test results.

  4. File them

    Keep them with your practice's compliance records.

Request sample documentation →

COA questions

More in the full FAQ.

Is every COA lot-specific?

Yes. Each Certificate of Analysis corresponds to a specific lot number, which matches the lot on your vial.

What does dual-lab mean?

Two separate test reports from two different laboratories for the same lot: the manufacturing lab and an independent third-party lab. You receive both.

Can I see documentation before ordering?

Yes. Sample COAs, NTA reports and specification sheets are available on request through our contact page.

Are passage number and population doublings on the COA?

They are not standard COA fields. Ask any supplier how expansion history is tracked for the lot you are buying.

Where and how is NTA measured?

On the final shipped exosome product, using NanoSight nanoparticle tracking analysis, with verification from the independent lab.

Why does a specification matter?

It is the acceptance limit the lot had to meet. A result is only meaningful next to the specification it was tested against.

Keep reading

Ask for the paperwork first

Request sample documentation before you order, or apply for wholesale access. Applications are typically approved within 24 hours.

Request documentationApply for wholesale access

For licensed medical professionals only. Exosome products are topical cosmetic products. hUCT-MSC products are individualized and not FDA-approved; use is clinician-directed, and patients should consult their primary care provider. Stem Nova Network does not provide dosing or procedural guidance. Products are not intended to diagnose, treat, cure, or prevent any disease. Stem Nova Network is a DBA of D1D Enterprises, Inc.